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Field Reports

March 15, 2019

Visit to the Clinical Site of Mycetoma Treatment Drug E1224 in Sudan

Reporter’s Profile
Katsura Hata
Global Health Research Section,
hhc Data Creation Center

Mycetoma is a serious infectious and inflammatory disease, which gradually destroys soft tissue. It is prevalent in an area across Africa, India and Central America called the “mycetoma belt”. Since its existence had been hardly known until now, it is called the most neglected tropical disease. In collaboration with Drugs for Neglected Diseases initiative (DNDi), Eisai has been conducting a Phase II clinical trial of E1224 for eumycetoma (fungal form of mycetoma) in Sudan with a grant from the Global Health Innovative Technology Fund since 2017. In summer 2018, we were given a valuable opportunity to visit Khartoum University, Mycetoma Research Center (MRC) where the clinical trial is being conducted and also Wad Onsa in Sennar state, an area where mycetoma is prevalent.

We received an explanation of the situation of the clinical trial from principal investigator Professor Ahmed H Fahal, and then took a look the facility at MRC. Approximately 200 patients usually visit MRC each day, and on this day the waiting rooms were crowded with many patients. We found many patients were using crutches and some patients have had their legs amputated. Professor Fahal said that although the current drug needs to be taken every day, E1224 only needs to be taken once a week, so if we can confirm efficacy, it would bring great benefit to patients from the viewpoint of compliance and medical expenses. Also he thanked Association for Aid and Relief, Japan (AAR), an international NGO who carries out activities to support mycetoma patients in Sudan. (the activity of AAR is being published on “From ATM Supporters Reports from the community”)

The next day, after 5 hours driving by car with the MRC medical team, we changed to a four-wheel drive car and drove for a couple of hours on a bad road, and finally arrived at Wad Onsa in Sennar state, an area where mycetoma is prevalent and located near the Blue Nile River (400 km south-southeast from Khartoum). There is a small clinic there, and an MRC medical team visits once every three months to provide medical care to residents in the surrounding 20 villages. Treatment basically consists of surgery, 10 to 20 people are newly diagnosed as mycetoma patients every week and usually 50 surgical operations are carried out. On this day a surgeon implemented 11 operations from the morning. Also because a 2 month old child was diagnosed with mycetoma, it seems that epidemiology and the infection route are not known at all. I saw patients who repeatedly relapsed and patients who had severe swelling on the soles of their feet, and I felt it would be great if E1224 could cure these patients with mycetoma. What I realized again in the car on the way back was that it is a burden physically and mentally for mycetoma patients to travel from around Wad Onsa to MRC in order to participate in the clinical trial. I strongly felt that we must leave no stone unturned in order to alleviate their burden.

Patients waiting for a doctor's examination – GHIT Fund
The affected part of mycetoma

Through this visit, it was amazing that we were able to confirm that clinical trials investigating E1224, which we were engaged in research and development on, are being implemented in the far distant Sudan and used for treatment of mycetoma patients. However, the mycetoma treatment drug development is still in progress. Even now, many mycetoma patients are suffering. We have to make the clinical trial successful, and we must think about partnering with other partners about drug supply after that. The goal is still far away, but we will push forward toward it. Finally, I would like to thank everyone at DNDi who planned this project and gave us a very valuable experience.

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